Development and Validation of Analytical Method for Simultaneous Estimation of Vardenafil and Dapoxetine HCl in Bulk and in Combined Dosage Form

Author(s)

Patel, P. D., Makwana, C. J., Patel, M. D., Dey, S., Upadhyay, U. M.

Author's Affiliation

Abstract

A simple, economic, selective, precise, and stability-indicating Reverse phase High Performance Liquid Chromatography method for analysis of Vardenafil and Dapoxetine HCl was developed and validated according to ICH guidelines. The quantification of the drug was carried out using Hypercil BDS C18 250mm × 4.6mm × 5μm or its equivalent in isocratic mode, with mobile phase compressing of Buffer (KH₂PO₄): Acetonitrile: Triethylamine (55: 45: 0.1 v/v/v) the flow rate was 1ml/min and the detection was carried at 266 nm. The retention time for Vardenafil and Dapoxetine HCl was found to be 3.673 and 5.070min respectively. The percent assay for Vardenafil and Dapoxetine HCl was found to be 100.22% and 99.44% respectively. The method was also applied for the determination of Vardenafil and Dapoxetine HCl in the presence of their degradation products formed under variety of stress conditions. Proposed method was validated for precision, accuracy, linearity range, specificity and robustness.

Keywords

Vardenafil, Dapoxetine HCl, RP-HPLC, Stability Indicating, Validation

Cite This Article

Patel, P. D., Makwana, C. J., Patel, M. D., Dey, S., & Upadhyay, U. M. (2014). Development and Validation of Analytical Method for Simultaneous Estimation of Vardenafil and Dapoxetine HCl in Bulk and in Combined Dosage Form. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 17-27.